Drug Approval | January 30, 2023
FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
It will help upgrade the infrastructure and technologies of the country's biopharmaceuticals and in-vitro diagnostic industry
The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
The Durezol brand and generic had US sales of approximately US $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA
The company will engage with the agency to resolve the import alert at the earliest.
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection
Cell sorting technology supports researchers advancing new therapies
Granules now have a total of 53 ANDA approvals from USFDA
The product will be manufactured at the plant of Bell, Sons & Co. (Druggists) Ltd. located at Gifford House, Slaidburn Crescent, Southport, UK
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
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